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On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA...Show More
On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA be granted. The CANOPY trial, which completed enrollment in November 2023, is evaluating VYD222's efficacy in preventing symptomatic COVID-19 and has shown promising early signs of clinical protection and a favorable safety profile. VYD222 has demonstrated in vitro potency against various SARS-CoV-2 variants, and if authorized, Invivyd plans to make it commercially available shortly thereafter.
2024 年 1 月 3 日，生物制药公司 Invivyd, Inc. 宣布向美国食品药品监督管理局 (FDA) 提交了其单克隆抗体候选物 VYD222 的紧急使用授权 (EUA) 申请，该单克隆抗体候选药物旨在预防免疫功能低下的成人和青少年 COVID-19 的暴露前预防。EUA的请求得到了正在进行的CANOPY 3期关键临床试验的积极初步结果以及针对当前SARS-CoV-2变体（包括快速传播的JN.1变体）的体外中和活性的支持。Invivyd 的首席执行官戴夫·赫林对 VYD222 的持续中和活动以及该公司针对保守表位以跟上病毒进化的步伐的战略方针表示了信心。如果获得欧盟许可，该公司还在为...展开全部
2024 年 1 月 3 日，生物制药公司 Invivyd, Inc. 宣布向美国食品药品监督管理局 (FDA) 提交了其单克隆抗体候选物 VYD222 的紧急使用授权 (EUA) 申请，该单克隆抗体候选药物旨在预防免疫功能低下的成人和青少年 COVID-19 的暴露前预防。EUA的请求得到了正在进行的CANOPY 3期关键临床试验的积极初步结果以及针对当前SARS-CoV-2变体（包括快速传播的JN.1变体）的体外中和活性的支持。Invivyd 的首席执行官戴夫·赫林对 VYD222 的持续中和活动以及该公司针对保守表位以跟上病毒进化的步伐的战略方针表示了信心。如果获得欧盟许可，该公司还在为可能的 VYD222 商业发布做准备。CANOPY 试验于 2023 年 11 月完成注册，正在评估 VYD222 在预防有症状的 COVID-19 方面的功效，并显示出令人鼓舞的临床保护早期迹象和良好的安全性。VYD222 已显示出对抗各种 SARS-CoV-2 变体的体外效力，如果获得授权，Invivyd 计划在此后不久将其上市。
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